NCT04141839

Brief Summary

The goal is to evaluate at three sites the implementation of the Safer Bars sexual assault prevention program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
681

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
12 months until next milestone

Study Start

First participant enrolled

October 16, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
4 months until next milestone

Results Posted

Study results publicly available

April 27, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

October 22, 2019

Results QC Date

March 13, 2025

Last Update Submit

April 9, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Who Reported Always Intervening Behavior at 6 Months

    Self-reported survey items measuring actual behavior (action taken) in response to observation of sexual aggression in the bar environment will be analyzed to identify significant differences post-intervention.

    at baseline and up to 6 months

  • Did Not Offer Promotions Aimed at Attracting Female Patrons Post-intervention

    Self-reported survey items completed by bar owners/managers regarding promotions aimed at attracting female patrons

    at baseline and up to 3 months

Study Arms (2)

Control

OTHER

Delayed intervention: baseline and 3-month assessment prior to receiving the Safer Bars training.

Behavioral: Safer Bars

Intervention

EXPERIMENTAL

This arm with consist of bars randomized to have the Safer Bars training on their premises attended by all their liquor serving staff with assessment directly before and after training (pre/post), and at 3 and 6 months post-training follow-up.

Behavioral: Safer Bars

Interventions

Safer BarsBEHAVIORAL

Safer Bars, a primary perpetration prevention program based on a bystander intervention model and the theory of planned behavior. Bar staff are trained to recognize and respond to sexual aggression and its precursors among patrons.

ControlIntervention

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both an employee and a liquor server, security official, or owner/manager of a bar randomly selected to receive Safer Bars training immediately or after an assessment only phase of 4 months and that has not participated in the Safe Bars training in the past 12 months. Accepts healthy volunteers as defined by holding active employment. Employees may opt out of training and/or assessment.

You may not qualify if:

  • None. No liquor servers are allowed by law to be younger than 19 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Related Publications (2)

  • Davis KC, Koss MP, Lopez EC, Roberts K. Safer Bars: A cluster-randomized effectiveness evaluation of alcohol-related sexual violence prevention through bar staff bystander training. Contemp Clin Trials. 2024 May;140:107488. doi: 10.1016/j.cct.2024.107488. Epub 2024 Mar 6.

    PMID: 38458561BACKGROUND
  • Roberts K, Davis KC, Koss MP, Lopez EC. Feasibility and Acceptability of a Bar-Staff Bystander Intervention Training Program for Reducing Sexual Aggression. J Stud Alcohol Drugs. 2025 Mar;86(2):238-245. doi: 10.15288/jsad.24-00031. Epub 2024 Oct 15.

Results Point of Contact

Title
Mary Koss
Organization
University of Arizona

Study Officials

  • Mary P Koss, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR
  • Kelly C Davis, MSW, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants use code numbers to submit their data.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: A cluster-randomized trial design with crossover to randomize participants at the bar level into intervention and delayed intervention arms.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Principal Investigator

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 28, 2019

Study Start

October 16, 2020

Primary Completion

November 1, 2023

Study Completion

December 31, 2024

Last Updated

April 27, 2025

Results First Posted

April 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

De-identified responses to survey questions will be provided to qualified investigators upon request with the time frame conditions described below. Any measures used that were developed or modified by the investigators will be provided as will the study protocol, SAP, and analytic code will be provided at any point after study completion to facilitate replication studies.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Five years after study completion, or sooner if requested by journal reviewers or colleagues for purposes of writing comments or critiques.
Access Criteria
Research institution

Locations